Acute Kidney InjuryPhase 2NCT03102021
The Effect of Human Recombinant Erythropoietin in Acute Renal Failure
A Phase 2 study testing erythropoietin and saline in people with Acute Kidney Injury, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of erythropoietin when used in high dose during acute kidney injury can decrease the number of days of kidney injury. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- erythropoietin and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age equal or greater than 21 yo
- acute neprhotoxic or ischemic kidney injury, acute tubular necrosis
Who cannot join
- no active or current malignancies
- not actively receiveing epo
- GFR less than 60 ml/min
- unable to provide informed consent
- contraindication to erythropoietin use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Dose Erythropoietin in Acute Renal Failure
The purpose of this study is to determine if the use of erythropoietin when used in high dose during acute kidney injury can decrease the number of days of kidney injury.
Read the detailed description
Acute kidney injury is associated with increased morbidity. The most common injury to the kidney occurs during hospitalization with either ischemic or nephrotoxic insult to the kidney. This can prolong hospitalization and depending on the severity of the insult result in permanent decreased kidney function. Recent studies in animals have suggested benefits of using erythropoietin in high doses at time of kidney injury with eividence for less injury in the kidney tissue of those animals who received treatment compared to those animals that received only saline. Limited human data also suggests that use of high dose erythropoietin at the time of stroke can decrease the extent of brain injury. In addition cardiac cell culture studies also have shown decrease in cell injury with use of erythropoietin. These studies have prompted us to evaluate if admininstering erythropoietin to those with onset of acute kidney injury during their hospitalization may benefit from this intervention. This pilot study then evaluates that use of high dose erythropoietin administed daily over 3 days in patients with acute kidney injury on whether the days spent in renal failure are less than those who will receive no study medication. Those patients with kidney failure from either ischemic or nephrotoxic insult and no other contraindication to erythropoietin use will be considered for the study. Informed consent is obtained from the patient or next of kin
- Conditions
- Acute Kidney Injury
- Being tested
- erythropoietin, saline
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Also called erythropoeitin
500 units/kg daily for 3 days at onset of acute kidney injury
salineDrug
Also called normal saline
saline 10 ml for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | erythropoeitin Receives: Drug: erythropoietin |
| 2 | Placebo comparator | saline placebo Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
days of acute renal failure
Measured: 28 days
Secondary outcomes (1)
days of hospitalization
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study startMar 2006
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Devasmita Dev, MD, North Texas Veterans Healthcare System
- Investigators
- Devasmita Dev, MD, Principal investigator, DAllas VA Medical Center/UT Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102021
- Sponsor's protocol ID
- #05-141
- Other IDs
- 092006-064 - UTSW protocol ID
- Status last verified
- Mar 2017
- First submitted
- 26 Dec 2007
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Dose Erythropoietin in Acute Renal Failure
- ClinicalTrials.gov ID
- NCT03102021
- Acronym / sponsor ID
- #05-141
- Conditions
- Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Mar 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the use of erythropoietin when used in high dose during acute kidney injury can decrease the number of days of kidney injury.
Detailed description
Acute kidney injury is associated with increased morbidity. The most common injury to the kidney occurs during hospitalization with either ischemic or nephrotoxic insult to the kidney. This can prolong hospitalization and depending on the severity of the insult result in permanent decreased kidney function. Recent studies in animals have suggested benefits of using erythropoietin in high doses at time of kidney injury with eividence for less injury in the kidney tissue of those animals who received treatment compared to those animals that received only saline. Limited human data also suggests that use of high dose erythropoietin at the time of stroke can decrease the extent of brain injury. In addition cardiac cell culture studies also have shown decrease in cell injury with use of erythropoietin. These studies have prompted us to evaluate if admininstering erythropoietin to those with onset of acute kidney injury during their hospitalization may benefit from this intervention. This pilot study then evaluates that use of high dose erythropoietin administed daily over 3 days in patients with acute kidney injury on whether the days spent in renal failure are less than those who will receive no study medication. Those patients with kidney failure from either ischemic or nephrotoxic insult and no other contraindication to erythropoietin use will be considered for the study. Informed consent is obtained from the patient or next of kin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: erythropoietinerythropoeitin |
| 2 | Placebo comparator | Drug: salinesaline placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age equal or greater than 21 yo
- acute neprhotoxic or ischemic kidney injury, acute tubular necrosis
Key exclusion criteria (5 listed)
- no active or current malignancies
- not actively receiveing epo
- GFR less than 60 ml/min
- unable to provide informed consent
- contraindication to erythropoietin use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erythropoietinAlso: erythropoeitin500 units/kg daily for 3 days at onset of acute kidney injury | Drug | 1 |
| salineAlso: normal salinesaline 10 ml for 3 days | Drug | 2 |
Primary outcome
days of acute renal failure
Time frame: 28 days
1 secondary outcome
days of hospitalization
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devasmita Dev, MD principal investigator
DAllas VA Medical Center/UT Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erythropoietin and saline in people with Acute Kidney Injury, run by North Texas Veterans Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
days of acute renal failure (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.